Current Regulatory Requirements for Conducting Clinical Trials in India for

IND/New Drug Version 2.0

Dr. Dhananjay K. Sable
Department of Biotechnology
Indian Institute of Technology, Madras

Lecture – 6B
Regulatory Pathway & Data Requirements for NDCT, 2019

Hello everyone, I hope you have enjoyed the previous lectures and I hope that you are
improving your knowledge about the New Drug and Clinical Trial Rules, 2019. In this
lecture that is lecture 6B we are going to see Regulatory Pathway and the Data
Requirement for New Drug and Clinical Trial, 2019. This is very important lecture for
you, those who require or those who are willing to apply for the clinical trials.

(Refer Slide Time: 00:45)

So, we are going to cover : what are the documents and requirements let us see one by
one. So, the expected outcome from this lecture that the learners will be able to know
what are the Rules under which they have to apply for the application to the clinical
trials; that is Rules associated with the clinical trials. Then what are the different types of
committees like IND committees, then New Drug Advisory committees. Which are the
committees, which evaluate your applications; dossier we are going to see. Then what
are the actual process where the scrutiny is completed, then at which stage the
committees see the dossier and applications and when we get the approval.
So, that the regulatory process will see, then data requirement of New Drug; what are the
data you require to submit while applying to the application for the New Drug approval.
Then again we are going to see the data requirement for Phytopharmaceuticals; the first
is the data requirement for New Drug and the data requirement for the
Phytopharmaceuticals.

(Refer Slide Time: 02:08)

So, let us start with our first slide that is legal provision for regulation of clinical trial.
So, before applying to the application for the New Drug or the clinical trial one must
know what are the Rules under which they are going to apply and what are the Rules
under which they are going to get a permission, approval.
(Refer Slide Time: 02:29)

The Rule 21st of the New Drug and Clinical Trial; this is regarding the application for
permission to conduct clinical trial of New Drug or the Investigational New Drug.

So, under this Rule that is Rule 21, you can apply to the licensing authority that is state
Central Licensing Authority. Then Rule 22 is a grant of permission to conduct a clinical
trial, so under Rule 22 you will obtain a permission to conduct Phase 1, 2 or 3; whatever
your application.

Then Rule 23 is permission to conduct clinical trial of New Drug or Investigational New
Drug as a part of discovery research and manufacture in India. Then the next Rule that is
Rule 24, it is regarding permission to conduct clinical trial of New Drug already
approved outside India.
(Refer Slide Time: 03:35)

The previous is for the manufacture in India and the next is for the drug which is
approved outside the India. Rule 25, it is related to the conditions of permission for
conduct of clinical trial; once you have obtained the clinical trial permission the
permission under this Rule 25, it gives some certain conditions which require to be
complied while conducting the clinical trials.

Rule 26 is the validity period; so under this Rule 26; the validity period for conducting or
initiating the clinical trial that has been given. Rule 27 is the post trial access of
Investigational Drug or the New Drug; after completion of the trial whether to give the
patients or subject the post trial access or not that is mentioned in this Rule. Rule 28, it is
related to the academic clinical trial; we have seen that academic clinical is not for the
commercial market and it should be initiated by the investigator and it is for only for the
academic purpose.
(Refer Slide Time: 04:38)

Rule 29, it is inspection of premises related to the clinical trial; under this Rule it has
been mentioned that the sites or the CROs, where the clinical trial is going on that should
be open for the regulator or the auditor those who have been appointed by the Central
Licensing Authority.

Rule 30 is the suspension or cancellation of permission; once you get the permission for
conducting the clinical trial or BA/BE study; so if the condition stipulated in that
permission is not complied with or if there is any violation of this conditions or Rules
regulation, then under the Rule 30 licensing authority can suspend or cancel the
permission.
(Refer Slide Time: 05:26)

Rule 75 is application for permission to import New Drug for sale or distribution; once
the trial has been completed then for the import under Rule 75 has to apply. Rule 76
grant of permission for import; once you have applied and the data is complete in all
respect, then you will get the permission to import that New Drug for sale and
distribution under Rule 76.

Rule 77 is the condition of permission for import of New Drug for sale and distribution.
So, the Rule 77 also stipulate the conditions after importing. So, while importing and
after importing; what are the conditions like it has to be stored in to the proper
conditions, it has to be imported from an authentic source that conditions has stipulated
under the Rule 77.

Rule 78 is the suspension or cancellation of import for a New Drug. So, if there is any
violation of the condition stipulated into the import permission or the drug which are
imported into the Indian market found to be sub-standard or not of quality standard; then
the import permission can be cancelled or suspended after giving a show cause notice, it
is mentioned in the Rule 78.
(Refer Slide Time: 06:47)

Then next Rule that is Rule 79; this is license to import New Drug for sale or distribution
under drug and cosmetic Rules; so this is under the 79; so this can be issued. Rule 80 is
the application for permission to manufacture New Drug for sale and distribution. So,
first we have seen the application for the import, then license for the import and under
this Rule it is application for manufacture.

Rule 81 is the grant of permission; so the first is the application and under Rule 81; it is
the grant of permission to manufacture New Drug for sale and distribution that is for the
marketing purpose. Rule 82 it is a condition of permission for manufacture New Drug.
So, under this 82 Rule; what are the condition the applicant and the applicant who has
obtain a permission to manufacture, what the condition they have to complied with given
under Rule 82.
(Refer Slide Time: 07:48)

Rule 83 is license to manufacture New Drug for sale and distribution, then Rule 84 is the
suspension or cancellation of the permission; in case of the violation. Rule 85, the
responsibility of importer or manufacturer marketing of a New Drug. So, what are the
responsibilities that has been given under Rule 85.

(Refer Slide Time: 08:10)

Now, moving towards the next slide that is which are the committees for the evaluation
of application; whereas, the application is with the licensing authority there is a
procedure we will see in our next slide what is the procedure. So, before that we will just
have the brief about the committees.

(Refer Slide Time: 08:28)

So, the first committee for approval of the application is the IND committee; this
committee is for the evaluation of Investigational New Drug, that is a new molecules.
We have seen the Investigational New Drug which is not approved elsewhere in the
world and first time it has to be administered to the subject or patient that is new
molecules discovered in the India.

So, such type of applications are evaluated under the IND committee which is chaired by
DG-ICMR and Secretary-Department of Health and Research along with the experts
from different fields and from the representative from the CDSCO; that is Central
Licensing Authority. The next committee is subject expert committee, this committee
comprises of 25 panels of and it is having around 350 medical expert across the country
and there are different types of classes of these committee based on the therapeutic areas.

For example, the committee is for the anti diabetic drug, oncology committee or for the
anti-microbial committee. So, depending upon the nature and the indication of the drug
there are different committees and such type of 25 panels are there and the panels they
mainly look after the New Drug those which are approved outside and not approved in
India.
(Refer Slide Time: 10:01)

Then we are having Technical Committee; this is a separate committee of experts chaired
by Director General Health Services, DGHS to assist Apex Committee for supervision of
a clinical trial. If the applicant is agreed by the decision of the subject expert committee,
then he can approach to the technical committee, which is chaired by the DGHS and
along with some experts.

In that committee also if he is not satisfied with the decision, then again there is a next
level committee that we called apex committee and it reviews the recommendation of the
technical committee and the subject expert committee and then it gives its own opinion.
(Refer Slide Time: 10:49)

Let us see what is the timeline and the automatic approval of clinical trial, what is this
automatic approval.

(Refer Slide Time: 10:55)

So, the timeline mention in the New Drug and Clinical Trial is 30 working days; if the
drug is discovered into the India. Under the provision to sub rule where no
communication has been received from Central Licensing Authority to the applicant
within the said period that is the 30 days for this drug which is discovered in India and
90 which is not discovered in India.
The permission to conduct clinical trials shall be deemed to have been granted by Central
Licensing Authority and such permission shall deemed to be legally valid for all
purposes and the applicant shall be authorized to initiate clinical trial in accordance with
these Rules. If within this 30 days time period; if there is no communication from the
licensing authority to the applicant; then that can be considered as a deemed approval.

(Refer Slide Time: 11:48)

Provided that he has to inform in to form CT-4A to the licensing authority that he has not
received any communication from the Central Licensing Authority within 30 days and
the drug is discovered into the India and the R&D has also been carried out into the India
and the drug is proposed for the manufacture marketing into the India; in such cases, if
we have not received any communication, it is considered in approval.

Then validity period of permission to initiate a clinical trial; so earlier there was no
validity period mentioned. Now, with this New Drug and Clinical Trial Rule; this
provision has been made to include the validity period and the validity period is two
years from the date of its issue.

Once the permission or approval has been obtained from the licensing authority, then the
applicant has to initiate clinical trial within period of two years and if it is not initiated
then that can also be extended provided that the applicant has to give a reason; why they
have not conducted the clinical trial study and after satisfying the Central Licensing
Authority can extend it.
(Refer Slide Time: 13:05)

Now, we will switch toward the data requirement. So, while applying we have seen the
various committees, we have seen various Rules under which the applicant has to file the
application; now we will see what is the data the applicant supposed to submit while
applying to the clinical trial.

(Refer Slide Time: 13:26)

So, this is the data which are required the chemical and pharmaceutical information
about the drugs. So, in detail the applicant has to submit the chemical and
pharmaceutical information. Chemical information like related to the chemistry of the
drug molecular formula, empirical formula, the structure of that drug, what is the name
of the API.

Then regarding pharmaceutical formulation the dosage form, dose, strength which is
proposed; all parameters related to the analytical validation, then the parameter related to
the solubility dissolution integrate integration this parameters have to be submitted. Then
detail about the animal pharmacology conducted, then animal toxicology conducted; then
phase I, II and III clinical trials. So, if the drug has been discovered in to the India or
outside the India; the studies which are conducted for the phase I, II and III that data has
to be submitted.

(Refer Slide Time: 14:30)

Then the regulatory status of that drug in other countries; if the drug is already approved
in other countries then whether that drug is continued to be marketed in that country or
whether it has been prohibited, withdrawn or cancel or if any side effect or adverse
effect associated with that drug because of which the drug has been banned in that
country that detailed information has to be submitted.

Then COPP that is a Certificate of Pharmaceutical Product or finish sale certificate

(FSC) in case of the import. If the applicant would like to import the drug, then whether
that drug is freely available in the market or not, whether that has been manufactured in
compliance with the GMP or not; the certificate of pharmaceutical product issued by the
concern NRA, National Regulatory Authority or licensing authority has to be submitted.
Then apart from this the labels and the prescribing information including the dosage
form, the precaution, warnings to be taken; whether it is schedule H drug, H1 drug etc.
What are the precaution to be taken; how the drug has to be taken that prescribing
information including label has to be submitted.

(Refer Slide Time: 15:48)

Data for conduct of clinical trial or import or manufacture of New Drug.

(Refer Slide Time: 15:54)

So, data for conduct of clinical trial; this is the data introduction It has to be given that is
the description and therapeutic class of the drug, then chemical, pharmaceutical
information for API and finish formulation, then data on the active pharmaceutical
ingredient that is physicochemical characteristic including empirical formula and
molecular formula that has to be given.

(Refer Slide Time: 16:21)

Then data with respect to the description like a solubility, then partition coefficient,
dissociation constant, then rotation, polymorphism, identification, enantiomerism all this
data related to the purity, impurity profile has to be submitted.

Then complete specification including; its identification identity, then impurity profile
analytical method validations; the method of assay, the method of determination of the
impurity including organic volatile impurity, then reference standard characterization,
final release specification, then its material safety, data sheet how to handle the material
what precaution has to be taken.

Then stability studies of the API as mentioned in the New Drug and Clinical Trial Rule
for 30 degree Celsius, for 45 degree Celsius for the 6 months that has to be submitted.
Then the forced degradation studies carried out to see the effect of the accelerated
conditions on the drug that is also required to be submitted.
(Refer Slide Time: 17:31)

Data on formulation; the data on formulation is the data with respect to the dosage form
if it is a tablet, capsule, injections, what are the dosage form that has to be given; then
what are the excipient use; the detail composition binder, then again diluents, the
quantity added for the compression that everything the quantity and the excipient name
has to be given. Then whether that is compatible with the excipient or not that study has
to be conducted and the result of the excipient compatibility study has to be submitted.

Then validation of analytical method; the method which are used for the determination
whether that method has been previously validated or not that validation report has to be
submitted. Then the master formula for the manufacturing of the dosage form that master
formula required to be submitted. Further, in process quality control check, then finish
products specifications; we have seen that APS specification has to be given; here again
the finish products specification has also required to be given. Then comparative
evaluation with the international brand; if the drug is available outside the India, then
what is the comparison with the approved brand that is also required to be submitted.

In India where applicable; pack presentation then dissolution study we know that
dissolution in (Refer Time: 19:08) dissolution study to see the drug release that is also
required to submit. Then assay, stability studies in intended pack; if it is a blister pack
then the stability study is required to be conducted in the same panel packaging material
and that is; that is required to be submitted, then packing specification, impurities,
content uniformity, PH wherever applicable. Then whatever the validation has been done
for the process that process validation also for the three batches; it has also required to be
submitted.

So, in the that was a related to the API and the dosage form; if it is the application for the
phase I trial, then the preclinical studies like animal pharmacology, animal toxicology
that is also required to be submitted.

(Refer Slide Time: 20:02)

In the animal pharmacology, the applicant require to provide summary of the study,
which is conducted with the animals. Then specific pharmacological action, general
pharmacological action then pharmacokinetic data like ADME data of sale and
distribution metabolism and execration in animals. Then the study conducted for the
follow up and supplemental pharmacological studies that is also required to be
submitted.

Then animal toxicology data including systematic toxicity study, male fertility study,
female reproduction developmental studies, then local toxicity study. If the product for
the external use, then dermal toxicity study, allergencity, then hypersensitivity studies;
this studies required to be submitted. Some this studies are required to be carried out in
animal and this studies may include (Refer Time: 20:59) maximization, dose
maximization study, then Local Lymph Node; what we call it is LLNA study, ocular
toxicity study if the product is to be used for the treatment of the eyes, then inhalation
toxicity study; all this studies required to be submitted depending upon the nature of the
drug and the intention of the treatment of the drug.

For certain drug and genotoxicity study, carcinogenicity study; those drug which are
having the long exposure for particular for those drugs this studies are required to be
submitted; where animal toxicity data has been submitted and the same is consider by the
regulatory authority on the country which has earlier approved the drug; the animal
toxicity study shall not be required to be conducted, in India except in case where there
are specific concerns recorded in writing.

(Refer Slide Time: 21:57)

If the animal pharmacology, animal toxicity study has already be conducted in other
countries; then that is now that is not required to be repeated in the Indian animals or the
pre clinical studies; unless there is a particular or special concern if the data is not
satisfactory, something is wrong happen with the animals; if the deaths are more, if the
toxicity is more then it require to repeat the data.

Then human or clinical pharmacological study after the pre clinical study that is the
clinical pharmacological study phase 1; we have seen what is the phase I study. So,
phase I they has to submit the protocol first and after the study, then has to give the
summary of the study, specific pharmacological effect, general pharmacological effect
then PK/PD study; it is require for the those which are required to be conducted for the
phase I study and for the early measurement of the drug.
(Refer Slide Time: 23:02)

Then phase II study same it has to be provided the summary; then study report as given
in the table 6 of the third schedule. So, third schedule of the New Drug and Clinical Trial
Rule, it mentions about the particulars to be submitted for phase II study. Phase III data
also require to be submitted after completion of phase II, here also the summary then
study report as given in table 6 of the third schedule that is required to be submitted.

If the drug is of particular nature; then the special study is required to be conducted and
the data required to be submitted. The special studies may be if the drug is particularly
for the geriatric patient or for the children’s, then the studies you know like behavioral
studies data and the studies conducted in the geriatric pediatrics or the pregnant or
nursing women; that is also required to be carried out and required to be submitted to the
licensing authority.
(Refer Slide Time: 24:07)

Regulatory status in other countries; we have seen whether the drug is released so
available in the market of other countries or whether it has been withdrawn or suspended
prohibited; if so, the reason of that that is required to be submitted.

Then prescribing information proposed full prescribing information draft of label and
carton. So, whatever the information the applicant or manufacturer is going to propose
on the draft label or the information; that label prescribing information also require to be
get approved from the licensing authority. Samples and test sample and testing protocol
samples of pure drug substance and finish product, at least 50 clinical dose with testing
protocol fully impurity profile and release specification.

So, this full impurity profile release specification are required to be submitted along with
the testing sample this; this licensing authority and they send this sample to the concern
laboratory and once the result of satisfactory result from that laboratory comes, then the
permission can be granted.
(Refer Slide Time: 25:22)

Then new chemical entity and the global clinical trial if any; assessment of risk versus
benefit to the patient, innovation visa vis existing therapeutic option, unmet medical need
in the country; if it is there the reason that has to be submitted and then copy of drug
license to manufacture any drug for sale granted by SLA in case the application is for
manufacture or sale of New Drug. So, this was about the; the New Drug that are the
chemical entity.

(Refer Slide Time: 25:53)

Again we have incorporated in our New Drug definition; we have seen the
phytopharmaceuticals. So, we will see what are the data requirement for the
phytopharmaceuticals.

(Refer Slide Time: 26:04)

Let us see first what is the phytopharmaceuticals; phytopharmaceutical drug means a

drug it is of purified standardized fraction. Assessed qualitatively and quantitatively with
defined four bio active or phytochemical compound of an extract of plant or its part; so,
there is a requirement of it should contain the minimum four bioactive phytochemical
compound. Further, we will add to this that this drug supposed to not being given in the
parenteral dosage forms, then we call it as the phytopharmaceutical.
(Refer Slide Time: 26:45)

Let us see what is the data requirement for the application of the manufacture of import
of the phytopharmaceutical. So, it is given in the second schedule table 4 data to be
submitted along with application to conduct clinical trial or import or manufacture of a
pharmaceutical drug in the country.

So, this data requirement has been given in the two parts that is part A and part B; we
will see first the part A. Part A is related to the data to be submitted by the applicant and
it is related to the human clinical data like human or clinical pharmacology information.

(Refer Slide Time: 27:28)

Then part B data generated by the applicant; first is the data submitted by the applicant
and part B. Data generated by the applicant data submitted by the applicant it means that
whatever the data available like publish literature or data from other countries; data
generated means this may be from the R and D of the applicant.

So, in this B part identification, authentication, source of plant used for extraction and
fractionation that is required to be submitted, then what are the processes used for the
extraction and subsequent fractionation and purification. Formulation of
phytopharmaceutical drug applied and for the manufacturing process of formulation,
then again here it is required to submit the stability data.

(Refer Slide Time: 28:18)

Safety and pharmacological information, then human studies, confirmatory clinical trial,
regulatory studies we have seen in case of the chemical entities that is in case of the
drugs also the regulatory status whether it is prohibited banned approved. Then
marketing information, post marketing surveillance and any other relevant information.
(Refer Slide Time: 28:41)

So, we have seen the phase III is mandatory to conduct before marketing approval has
been obtained, but there are certain cases where in the clinical trial can be; phase III
clinical trial can be waved off.

(Refer Slide Time: 28:56)

For New Drug substance discovered in India; these are some important things which we
are required to be know. Now, for New Drug substance discovered in India clinical trial
is required to be conducted right from phase I. For New Drug approved outside India,
phase III studies need to be carried out to generate evidence of safety efficacy in Indian
population that we have seen.

(Refer Slide Time: 29:20)

(Refer Slide Time: 29:23)

So, as per the Rule 24; not with the standing anything containing these Rules what we
have seen in the in our previous slides the Rules, where any person or institution or
organization makes as application under Rule 21 to conduct clinical trial of New Drug
which is already approved and marketed in country; as specified under Rule 101.
So, the countries for the consideration that would be notified under the Rule 101, the
application shall be disposal of by way of grant of permission or rejection or processed
by way of communication to rectify any deficiencies; as the case may be as specified in
Rule 22 by Central Licensing Authority within a period of 90 working days from the
receipt of the application. So, if it is for the import; if it is a import case within 90 days
the application required to be disposed of either by rejection or the either by query or
other by the approval.

(Refer Slide Time: 30:26)

So, the Rule 101 mention that the Central Licensing Authority with the approval of the
Central Government may specify by an order the name of the countries from time to time
for considering the waiver of local clinical trial for approval of New Drug under chapter
10 and for grant of permission for conduct of clinical trial under chapter 5.

So, this Rule mentions the notification of the countries; the Central Government that is
Central Licensing Authority with the approval of Central Government will specify the
name of the countries which are Indian regulatory authorities; if the drug is available in
that countries and the applicant desired to import that drugs. So, that can be waived of
the phase phases of the clinical trial that is phase III can be waive of.
(Refer Slide Time: 31:20)

So, you can see the slide wherein the diagram has been given for the regulatory pathway
for approval of the New Drug or the IND. So, this is the actually the procedure what the
applicant and the regulators has to be followed; you can see the slide.

The application for import or the manufacturing; so, there can be two type of application.
The drug can may available in to the India by the import or by the manufacturing and the
drug can be a New Drug or the drug can be an Investigational New Drug. For both of
this; this application has to submitted, we have seen the application forms and the fees.

Irrespective of whether the application is for import or manufacture; if it is not approved,

then application for CT has to be given. The CT protocol with respect to the design,
population that is that undergoes the preliminary examination at the CDSO that is
Central Licensing Authority and after the preliminary examination with respect to the
chemical pharmaceutical data and some administrative like a forms, fees these goes to
the evaluation committee.

We have seen the evaluation committee, IND committee; if it is the new molecule, then
it goes to the IND committee. If it is a New Drug, then it goes to the subject expert
committee and after evaluation by this committee; the committee gives the
recommendation either they may they may ask the applicant to modify or amend the
protocol, in that regard they may issue the query to the applicant. Once the applicant
receives the query; he has to respond to that query and once that has been responded that
query whether they have amended the protocol as per the SEC committees
recommendation or not

That is again evaluated by the SEC committee and in case of the IND by the IND
committee. After that again this SEC committee after detailed deliberation give its
opinion and that opinion may be approval of the rejection. If the query raised by the SEC
committee or the Central Licensing Authority; if it is not satisfied, then application can
be rejected or if it is to the satisfactory level; then approval can be given to conduct the
clinical trials.

Then once the clinical trial has been approved, the applicant require to conduct the
clinical trial and after conducting clinical trial; it require to submit the detailed report that
the study report and the outcome of the clinical trial; that is again evaluated by the SEC
committee or the IND committee. And if that results are satisfactory and if it is or the
benefit of the patient; then that committee gives not to the applicant and after that if the
applicant would like to import that drug, then he has to apply for the import.

If it is the case of the manufacture, then he has to apply through the manufacturing
pathway. Then after seeing all this if it is for the manufacturing, he has to submit all the
details of the manufacturing premises. If it is a case of the import, then details of the
manufacturing country or that country they have to submit and after satisfactory
submission of this; the permission can be granted for the manufacture of the import of
the drug. So, this is the regulatory pathway.
(Refer Slide Time: 35:16)

So, the applicant has to apply through the online portal. The approval process through
online portal for grant of license for New Drug; we will see in brief how to apply and
how it goes to the panel conclusion. The applicant user has to register on the portal that
we call the SUGAM portal.

Then it will generate the user profile and manufacturer address repository, then the
applicant has to select application type and category whether it is New Drug, IND,
veterinary, vaccine that we have to select. Then the applicant has to upload the
undertaking for providing correct information. The undertaking which will specify that
the whatever the information they are submitting that is true that undertaking has to be
submitted or uploaded on the SUGAM portal.

Then the applicant required to upload the information regarding the manufacturer
detailing; if it is the manufacturing; then manufacturer detail, if it is import then
importers detail. After that the applicant required to submit the details of the New Drug;
what we have seen in our earlier slides regarding pharmaceutical, chemical information,
regarding the New Drug detail we have to submit.

Then there is a checklist has been given on the SUGAM portal for the different
categories of the drug and different type of the drug; we have to select the category. If it
is for the manufacturer, then there is different checklist; if it is for the import purpose
different checklist. If it is for the clinical trial, then what are the data requirement that has
been mention in the checklist; the applicant required to fill up that checklist.

Then upload payment challan; so this payment can be whatever the fees; we have seen in
earlier slides that fees has to be uploaded. This fees in case; this fees in like a receipt they
have to upload. If it is paid through the Bharat Kosh, then in that Bharat Kosh receipt or
if it is paid in into the Bank of Baroda where to pay the fees that has also to be mention
in our Rule and so that fees paid challan or receipt has to be uploaded. Then submission
of application by the applicant, then after uploading all this they have to submit it.

(Refer Slide Time: 37:51)

Once the part from the application is over, then it is on the regulatory side that is
application received by the nodal officer; so it goes to the nodal officer. Application then
forwarded to the reviewing officer. So, after the scrutiny whether the application is
completed in all manner that will be looked after by the nodal officers and if it is they
will forward it to the reviewing officer.

Reviewing officer after scrutinizing and reviewing the application, forward to the nodal
officers. Then nodal officer giving its recommendation and after reviewing, forward it to
the decision taking authority or the decision authority. If any deficiency in document,
then at this level the query would be raised on and this query would go directly in the
mail of the applicant.
Then after satisfactory response from the applicant, it is again forwarded to the DDA or
DA. Then DDA that is a decision taking authority; will forward the application to the
Central Licensing Authority for the approval purpose and once the Central Licensing
Authority sees it that the application is in complete in all manner, it may grant the license
and the permission is generated online.

Then after generation of this permission; that is digitally signed by the Central Licensing
Authority and that permission then is uploaded on to the website that can be seen or
downloaded by the applicant. So, this is the online procedure.

(Refer Slide Time: 39:37)

So, this is all about our lecture and we will have the summary what we have seen in this
lecture. So, we have seen various Rules under the legal provision for regulation of
clinical trial. Then we have seen the various Rules related to the import related to the
manufacture related to the test license.

Then we have seen the various committee like if the drug is for the Investigational New
Drug/New Drug; then IND committee. If it is a New Drug then Subject Expert
committee, then we have seen the Technical committee, Apex committee in case of the
applicant; if it is a aggrieve by the decision of the previous committee. Then we have
seen the data requirement; what are the document required for the New Drug and what
are the document required for the phytopharmaceuticals that we have seen. We have also
seen that the phase III is the mandatory for before the marketing of the drug into the
country. But we have also seen that there are some conditions wherein the phase III can
be waived of; then we have seen the requirement of local clinical trials andfurther we
have seen the procedure, regulatory pathways and how to apply to the portal and how it
moves from the reviewing officer to the Central Licensing Authority on the
SUGAMonline portal. So, the last we will take recap of this by checking your memory
and attention.

(Refer Slide Time: 41:21)

So, the first question for you; you have two state true or false; for New Drug application
data from animal pharmacology is necessary. Yes, it is a required; if it is a phase I and
then the data is 1, 2, 3; the data from the animal pharmacology is necessary. The next
question is the fill in the blank the IND committee is chaired by?

So, the IND committee is chaired by DG-ICMR and Secretary, Department of Health
and Research. Permission to conduct clinical trial of New Drug already approved outside
India is stated under which Rule? So, this is a Rule 24.
(Refer Slide Time: 42:20)

Next question, minimum how many bio active phytochemical compound are required to
be assessed in a phytopharmaceutical drug? So, you have to recall the definition of
phytopharmaceutical and the answer is minimum four bio active phytochemical
compounds. So, this is about the lecture 6B; we will, we will see the next provisions and
what is there again in the New Drug and Clinical Trial Rules in our next lecture. Till
then; you take care, all the best.

(Refer Slide Time: 42:59)

And thank you for watching this video.